We finally finished reading the whole thing and wanted to bring your attention to Module 2 (Summary of Quality Information), Section D (Product Handling At The Clinical Site). Please read the following excerpt from that document and, if you are uncertain how to comply, then call us (or stop by to see us at the upcoming shows in Boston and London).

Module 2. Summary of Quality InformationSection D. Product Handling at the Clinical Site

Proper control of the finished DP is critical to your investigational studies. Therefore, your IND should also include a description of how the product will be shipped to, received, and handled at the clinical site to ensure safety, product quality, and stability. Your IND should also include information on shipping conditions, storage conditions, expiration date/time (if applicable), and chain of custody from the manufacturer to the site of administration in the summary information of the CTD. Your summary in Module 2 should also include information for product handling at the clinical site prior to administration (such as thawing, washing, or the addition of diluent or adjuvant, loading into a delivery device, and transport to the bedside) and summary information on product stability prior to and during administration (e.g., in-device hold times and temperatures).

Our evo system (evo hardware + evo.is) currently supports the guidance advise relating to shipping condtions, storage conditions expiration date/time, chain of custody, and handling at the clinical site to the bedside.

We are proud to have lead the way in the awareness of these needs and to have developed a solution for these needs. Our system is IND ready!